Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Fluorometer
510(k) Number K864699
Device Name FLUORESCENCE CONCENTRATION ANALYZER (FCA)
Applicant
Pandex Laboratories, Inc.
909 Orchard St.
Mundelein,  IL  60060
Applicant Contact HANK JUSKE
Correspondent
Pandex Laboratories, Inc.
909 Orchard St.
Mundelein,  IL  60060
Correspondent Contact HANK JUSKE
Regulation Number866.4520
Classification Product Code
JZT  
Date Received12/02/1986
Decision Date 12/22/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-